CDSCO panel gives Emcure Pharma waiver on Phase IV CT for Lamivudine plus Dolutegravir
New Delhi: Pharmaceutical major, Emcure Pharmaceuticals has got approval from the Subject Expert Committee (SEC) functional under Central Drug Standard Control Organization for Phase IV clinical trial waiver of antiviral fixed-dose combination Lamivudine 300 mg plus Dolutegravir 50mg tablets
This came in line with the proposal presented by the firm along with the first PSUR (Periodic Safety Update Report) data.
Dolutegravir-lamivudine is an antiretroviral fixed drug combination tablet. It is approved for initial therapy for the treatment of individuals who have no known or suspected resistance to these two drugs. This fixed drug combination decreases the chance of developing acquired immunodeficiency syndrome (AIDS) and HIV-related illnesses such as serious infections or cancer.
This fixed drug combination of dolutegravir and lamivudine is used alone to treat human immunodeficiency virus (HIV) infection in people who have never been treated with any HIV medications before or in people who have responded well to their HIV medication regimens and have no history of poor response to their past HIV regimens.
Lamivudine is in a class of medications called nucleoside analogue reverse transcriptase inhibitors (NRTIs). Dolutegravir is in a class of medications called integrase strand transfer inhibitors (INSTIs). They work together to reduce the amount of HIV in the blood.
Earlier at 109th SEC meeting for Antimicrobial & Antiviral, the firm presented their proposal before the committee requesting for Phase IV clinical trial waiver. At the same meeting, the firm presented various international studies on the FDC and also informed that this use of the FDC is also recommended in WHO 2021 guidelines before the committee.
In addition, the committee noted that the FDC of Dolutegravir + Lamivudine + Abacavir is already approved. Also, it was noted that as part of the manufacturing and marketing permission the first PSUR of the FDC is likely to be submitted.
Now in continuation, at the 112th SEC meeting for Antimicrobial & Antiviral held on 21.04.2022, the expert panel reviewed the proposal presented by drug maker Emcure Pharmaceuticals along with the first PSUR data of fixed-dose combination Lamivudine 300 mg plus Dolutegravir 50mg tablets.
The committee noted that the FDC is already approved in the US, UK, Australia, Japan, etc., and is also recommended in WHO 2021 guidelines.
After detailed deliberation, the committee recommended the Phase IV clinical trial waiver.
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